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Do for-profit stem cell studies have inherent potential biases?

There’s been an interesting and diverse discussion going on here on this blog lately related to some stem cell translational things including a stem cell clinic operating in Sacramento (see 50+ comments on that post) and then more recently on a new paper from the Centeno clinic.

.@pknoepfler Did most (or all) participants in this study pay out-of-pocket for their stem cell interventions? Did $ go to any authors?

Over on Twitter, Leigh Turner raised the valid point that he didn’t see a conflict of interests or competing interests statement in the Centeno paper. I didn’t see one either. Most journals require such statements. In this case, such a statement would have been important because unless I missed something, one or more of the authors profited from the study itself via charging patients.

This also raises the question of whether any given for profit stem cell clinical study has inherent biases, which could even be unconscious. Why? Providers in such a context benefit if the results are encouraging and patients who pay for experimental medical therapies may have a stronger placebo effect.

On one level the same kind of bias could come into play to some extent in certain academic or biotech stem cell clinical settings too if those running the studies have potential financial interests in the outcomes.

The best way to deal with such potential factors is to have rigorous controls and for those running the studies to be aware of and disclose potential conflicts and biases as well as potentially consulting with a bioethicist.

Looks like a business deal rather than research, and that’s maybe why they do not see a “conflict of interest” as far as there is a private commercial agreement and a good insurance. The problem is that they call it a clinical trial…

@T.Suzuki,
I would have thought the journal would still require a statement, but perhaps not.
As to your statement on calling this a clinical trial, I suppose it depends on one’s definition. Here’s one definition from the web “For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” This study would seem to fit this definition. Perhaps you mean it isn’t a traditional, phased (Phase I, Phase II, etc.) trial testing an IND?
Paul

Perhaps the journal doesn’t do the conflict of interests statement thingy. Regardless, Dr Centeno makes no bones about linking the work to his group of medical practitioners. Indeed, he’s pretty blunt about most things on his website. I like that.

I never believe the conflict of interest statement, anyway. (I admit to a pathological hatred of box-checking.) I prefer to look at the broader context and make up my own mind about who has what sort of conflict of interest.

Everyone has a bias from the point of view of someone else. Your post about ARM prompted me to spend a little time exploring their website. Predictably, their position on REGROW seemed well aligned with their preferred business model. Dr Centeno had a more ambivalent position on REGROW, as he explained in the context of his own model for advancing stem-cell therapies.

Personally, I like lots of models for advancing all sorts of science. Call me a scientific anarchist in that regard.

I’m more comfortable with people who admit that they have biases and that they probably are almost as biased as Brian Sanderson and so they know that they don’t even know what all their biases are.

When it comes to bioethics, it’s always interesting to get another perspective by at the end of the day ethics isn’t something that I’d ever outsource.

Well, CIRM has done things the “right” way, has it not? After spending almost a decade of time and a few billion dollars of tax payer money, they’ve come up with pretty much… nothing. So, exactly how is it that a very small company, especially one without crony connections to an organization like CIRM that can grant them tens of millions of public dollars (ex. Stem Cells Inc) to develop a patented product that the public will then have to pay to use (assuming they actually ever develop anything useful, like an actual treatment), supposed to develop a new “drug” like an autologous stem cell treatment?

Any decent business person knows that once your company is entrenched into a dominant position, the next move is to push for legislation to create a barrier of entry as high as possible to dissuade competition. This explains the symbiotic relationship between Big Pharma and the FDA. Both benefit by more regulation.

And this is why you see patients and small companies pushing for less regulation of autologous stem cell treatments while entrenched interests push back to maintain the status quo or even increase the amount of regulation.

Bias is a serious impediment for science. In the world of business, bias can be very useful, indeed. This is so much so that sometimes I wonder if regulation, politics and business aren’t more about exploiting science than doing science. (Truthfully, I don’t need to wonder.)

I suggest that the problem is systemic. Pointing fingers about the other guy’s bias won’t solve it.

We should ask ourselves the question: How did science become the handmaiden of business and politics?

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